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Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

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ClinicalTrials.gov Identifier: NCT02810509
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Keun-Sik Hong, Inje University

Study Description
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Brief Summary:
The current study aims to assess the quality of anticoagulation with warfarin in real world practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and to explore predictors for poor International Normalized Range (INR) control.

Condition or disease
Atrial Fibrillation Stroke

Detailed Description:
  • To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).
  • To explore predictors for poor INR control.

Study Design
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Study Type : Observational
Actual Enrollment : 1814 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Groups and Cohorts
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Group/Cohort
Short-term Warfarin-treated cohort
  1. admission due to AF-related ischemic stroke (known AF or newly detected AF)
  2. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment
  3. TTR evaluable days < 90 days
Long-term Warfarin-treated cohort
  1. admission due to AF-related ischemic stroke (known AF or newly detected AF)
  2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
  3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment
  4. TTR evaluable days ≥ 90 days


Outcome Measures
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Primary Outcome Measures :
  1. Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0. [ Time Frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years) ]
    The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.


Secondary Outcome Measures :
  1. Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured. [ Time Frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years) ]
    The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients who admitted to 16 participating centers due to AF-related ischemic stroke between Jan 1, 2011 and Dec 31, 2012 and started warfarin therapy for secondary stroke prevention will be enrolled in this study. The number of patients is expected to be 2,217 for the warfarin-initiated cohort and 1,057 for the long-term warfarin-treated cohort.
Criteria

Inclusion Criteria:

Inclusion criteria for the warfarin-initiated cohort

  1. Admission due to AF-related ischemic stroke
  2. Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period
  3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment

Inclusion criteria for the long-term warfarin-treated cohort

  1. Admission due to AF-related ischemic stroke
  2. Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
  3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
  4. TTR evaluable days ≥ 90 days

Exclusion Criteria:

  1. AF with mechanical valve
  2. Enrollment in anticoagulation randomized clinical trial
  3. Enrollment in studies affecting the target INR range.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810509


Locations
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Korea, Republic of
Hallym University College of Medicine
Anyang, Korea, Republic of
Dong-A University College of Medicine
Busan, Korea, Republic of
Yeungnam University School of Medicine
Daegu, Korea, Republic of
Dongguk University Ilsan Hospital
Goyang, Korea, Republic of
Chonnam National University Medical School
Gwangju, Korea, Republic of
Ilsan Paik Hospital Inje University
Ilsan, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Jeju National University Hospital, Jeju National University College of Medicine
Jeju, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Eulji General Hospital, Eulji University School of Medicine
Seoul, Korea, Republic of
Korea University College of Medicine
Seoul, Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of
Soonchunhyang University College of Medicine
Seoul, Korea, Republic of
Soonchunhyang University
Seoul, Korea, Republic of
University of Ulsan College of Medicine
Seoul, Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Keun-Sik Hong, MD, Phd Department of Neurology, Ilsan Paik Hospital Inje University
More Information
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Responsible Party: Keun-Sik Hong, Professor, Inje University
ClinicalTrials.gov Identifier: NCT02810509     History of Changes
Other Study ID Numbers: Warfarin TTR-01
First Posted: June 23, 2016    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Keun-Sik Hong, Inje University:
Wafarin
Cardioembolic (CE) stroke
ischemic stroke
Additional relevant MeSH terms:
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Warfarin
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anticoagulants